Major Depressive Disorder (MDD)MDD/AE/MBNCT07625163
The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia
A study testing Aerobic exercise and Mindful Breathing in people with Major Depressive Disorder (MDD), run by University of Pretoria at 2 sites in Saudi Arabia.
Trial summary
The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Aerobic exercise and Mindful Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 15 Jun 2026to 14 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.
- A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile
Who cannot join
- Patients with high suicidal ideation
- Patients with a history of psychosis or bipolar disorder
- Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).
- Concurrent participation in other structured exercise/mindfulness trials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites
Erada Hospital and Mental Health in Al Kharj
Al Kharj
Dawood F Aldawood, +966505109089, dfaldawood@moh.gov.sa
Erada complex and Mental Health in Riyadh
Riyadh
Salwa M Abdulrahim, +966508832162, sabdulrahim@moh.gov.sa
About this study
Official title: The Effects of Aerobic Exercise and Mindful Breathing on Symptom Severity and Quality of Life in Individuals With Major Depressive Disorder in Saudi Arabia: A Randomised Clinical Trial Protocol
The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. The main question is: Does aerobic exercise and mindful breathing delivery reduce depressive symptom severity and improve quality of life more effectively than standard psychiatric care? The aims to answer are:
- To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.
- To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.
- To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.
- To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.
Read more
Participants will be randomized into three groups:
- 45 minutes of moderate AE (60-75% HRR);
- 15 minutes of guided mindful breathing (6 breaths/minute);
- a waitlist control receiving standard care. *Interventions will occur three times a week for 16 weeks.
Read the detailed description
Major Depressive Disorder (MDD) is a leading cause of global disability, with many patients showing suboptimal responses to conventional pharmacological treatments. Evidence suggests that aerobic exercise (AE) and mindful breathing (MB) can serve as powerful non-pharmacological modulators of the central and autonomic nervous systems. This protocol outlines a randomized clinical trial (RCT) to evaluate the individual and synergistic effects of these interventions in a Saudi Arabian clinical population.
Major Depressive Disorder (MDD) is no longer viewed merely as a psychological condition but as a systemic, multi-faceted public health crisis. According to the World Health Organization and the latest Global Burden of Disease (GBD) analysis, MDD is a primary driver of global disability, defined by persistent feelings of sadness, anhedonia, sleep disturbances, and diminished capacity for daily functioning . Globally, it affects more than 280 million people.
In Saudi Arabia, the rising prevalence of MDD necessitates a shift toward "Integrative Psychiatry," where lifestyle medicine serves as a core pillar. Despite the availability of pharmacological and psychotherapeutic treatments, many individuals experience suboptimal outcomes, relapse, or treatment resistance, with the STAR*D study highlighting that only about one-third of patients achieve full remission after their first course of antidepressant medication . Furthermore, the side effects of conventional medications, such as weight gain and metabolic syndrome, often lead to premature discontinuation.
While the individual antidepressant effects of exercise and mindful breathing are well-documented, significant gaps remain. Existing literature indicates that AE "primes" the brain by increasing neuroplasticity and reward processing. Mindful breathing, conversely, stabilizes the autonomic nervous system and reduces anxiety. Combining these two low-cost, non-pharmacological interventions may provide a superior "biopsychosocial" approach to MDD recovery that neither could achieve alone. Modern psychiatry recognizes that a patient can be "less depressed" while still having a poor Quality of Life (QoL). Exercise is uniquely positioned to improve QoL because its benefits are "transdiagnostic", improving physical vitality, sleep quality, and social engagement simultaneously.
and a baseline Hamilton Depression Rating Scale (HAM-D) score ≥ 17.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Aerobic exercise, Mindful Breathing
- Keywords
- Major Depressive Disorder, Aerobic Exercise, Mindful Breathing, Quality of Life, Saudi Arabia
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Also called walking, cardiovascular exercise
Aerobic or cardiovascular exercise is characterized by activities that engage large muscle groups, including walking, jogging, or cycling. Regular aerobic exercise can improve cardiovascular health, endurance, and overall fitness.
Mindful BreathingOther
Also called diaphragmatic breathing, deep breathing
Mindful breathing can include diaphragmatic breathing, deep breathing, and controlled breathing techniques, which focus on regulating and optimizing the process of inhalation and exhalation. These techniques enhance respiratory function, increase lung capacity, and promote relaxation by activating the parasympathetic nervous system. Therefore, they have been used in various therapeutic contexts to manage stress, anxiety, and mood disorders, including MDD, by regulating emotions and the stress response.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise (AE) | Experimental | The AE protocol is designed to achieve the moderate-intensity threshold (SMD = -0.91), which has been identified as the most effective for symptom reduction (16).
* Warm-up: 5-10 minutes of low-intensity walking and dynamic stretching.
* Core Phase: 30 minutes of continuous aerobic activity (walking or Stationary Cycling).
* Intensity Monitoring: Heart rate (HR) will be monitored using wearable sensors. Target intensity is set at 60-75% of the Heart Rate Reserve (HRR) or a Rating of Perceived Exertion (RPE) of 12-14 on the Borg Scale.
* Cool-down: 5 minutes of slow walking and static stretching. Receives: Other: Aerobic exercise |
| Mindful Breathing (MB) | Experimental | The MB protocol focuses on "Top-Down" emotional regulation and "Bottom-Up" autonomic stabilisation.
* Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for four (4) seconds and exhaling slowly for six (6) seconds (approximately 6 deep breaths per minute).
* Mindfulness Component: During the breathing, participants are instructed to maintain "non-judgmental awareness," acknowledging stray thoughts and gently returning focus to the sensation of air entering and leaving the body.
* Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. Receives: Other: Mindful Breathing |
| Control Group (Standard Care) Standard Treatment | Other | Participants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions. Receives: Other: Aerobic exercise; Other: Mindful Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom severity
Depressive symptom severity will be assessed using the Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms.
For MDD, a baseline Hamilton Depression Rating Scale (HAM-D) score of ≥ 17 is required. Reduction in Hamilton Depression Rating Scale (HAM-D) scores is the primary outcome measure.
Measured: Baseline, Week 4,8, and a 16-week
Secondary outcomes (3)
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which generates domain scores transformed to a scale ranging from 0 to 100. Higher scores indicate a better quality of life
Measured: WHOQOL-BREF: baseline and week 16.
Quality of life (QoL)2 : Anxiety Symptoms
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.
Measured: Baseline, Week 4,8, and a 16-week
Quality of life (QoL) 3: Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline, Week 4, Week 8, and Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Aerobic Exercise (AE) Administration The AE protocol is designed to achieve the moderate-intensity threshold * Warm-up: 5-10 minutes of low-intensity walking. * Core Phase: 30 minutes of continuous aerobic activity (walking). * Cool-down: 5 minutes of slow walking and static stretching. Group II: Mindful Breathing (MB) Administration * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for 4 seconds and exhaling slowly for 6 seconds (approximately 6 breaths per minute). * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. Group III: Control Group (Standard Care) : Participants will continue their prescribed pharmacological treatment and any existing psychotherapy or physiotherapy sessions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad Bin Muaythir, University of Pretoria
- Investigators
- Saad Bin Muaythir, Master, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625163
- Sponsor's protocol ID
- 680/2024
- Acronym
- MDD/AE/MB
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indirect identifiers will be used through coded participant IDs. Direct identifiers will be stored separately from research data. Use participant codes on all study forms; store consent forms separately; keep electronic data on password-protected/encrypted devices or servers; keep paper CRFs in locked cabinets; restrict access to PI and authorized research staff only.
Publications
1. WHO. Depressive disorder (depression): World Health Organization; 2025 [Available from: https://www.who.int/news-room/fact-sheets/detail/depression.
GBD 2023 Demographics Collaborators. Global age-sex-specific all-cause mortality and life expectancy estimates for 204 countries and territories and 660 subnational locations, 1950-2023: a demographic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 18;406(10513):1731-1810. doi: 10.1016/S0140-6736(25)01330-3. Epub 2025 Oct 12.
PubMed 41092927Alnaim MA, Alghamdi AH, Aljawair MR, Alhadi FA, Alomair AM, Alsaad A. Depression among Saudi international university students and its associated risk factors. BMC Public Health. 2024 Nov 11;24(1):3101. doi: 10.1186/s12889-024-20565-y.
PubMed 39523315Pigott HE, Kim T, Xu C, Kirsch I, Amsterdam J. What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study's patient-level data with fidelity to the original research protocol. BMJ Open. 2023 Jul 25;13(7):e063095. doi: 10.1136/bmjopen-2022-063095.
PubMed 37491091Romero Garavito A, Diaz Martinez V, Juarez Cortes E, Negrete Diaz JV, Montilla Rodriguez LM. Impact of physical exercise on the regulation of brain-derived neurotrophic factor in people with neurodegenerative diseases. Front Neurol. 2025 Jan 28;15:1505879. doi: 10.3389/fneur.2024.1505879. eCollection 2024.
PubMed 39935805Komariah M, Ibrahim K, Pahria T, Rahayuwati L, Somantri I. Effect of Mindfulness Breathing Meditation on Depression, Anxiety, and Stress: A Randomized Controlled Trial among University Students. Healthcare (Basel). 2022 Dec 22;11(1):26. doi: 10.3390/healthcare11010026.
PubMed 36611488Bin Muaythir S, Bello B, Mshunqane N, Ramano E, Magida N. Effect of Aerobic exercise on depression symptoms and quality of life in Patients with major depressive disorder: a systematic review Protocol. BMJ Open. 2026 Jun 10;16(6):e112841. doi: 10.1136/bmjopen-2025-112841.
PubMed 42270109Marquez DX, Aguinaga S, Vasquez PM, Conroy DE, Erickson KI, Hillman C, Stillman CM, Ballard RM, Sheppard BB, Petruzzello SJ, King AC, Powell KE. A systematic review of physical activity and quality of life and well-being. Transl Behav Med. 2020 Oct 12;10(5):1098-1109. doi: 10.1093/tbm/ibz198.
PubMed 33044541Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14.
PubMed 28286859Jenkins DG, Quintana-Ascencio PF. A solution to minimum sample size for regressions. PLoS One. 2020 Feb 21;15(2):e0229345. doi: 10.1371/journal.pone.0229345. eCollection 2020.
PubMed 32084211
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise and Mindful Breathing on Symptom Severity and Quality of Life in Individuals With Major Depressive Disorder in Saudi Arabia: A Randomised Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07625163
- Acronym / sponsor ID
- MDD/AE/MB / 680/2024
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Aerobic Exercise, Mindful Breathing, Quality of Life, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. The main question is: Does aerobic exercise and mindful breathing delivery reduce depressive symptom severity and improve quality of life more effectively than standard psychiatric care? The aims to answer are:
- To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.
- To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.
- To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.
- To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.
Participants will be randomized into three groups:
- 45 minutes of moderate AE (60-75% HRR);
- 15 minutes of guided mindful breathing (6 breaths/minute);
- a waitlist control receiving standard care. *Interventions will occur three times a week for 16 weeks.
Detailed description
Major Depressive Disorder (MDD) is a leading cause of global disability, with many patients showing suboptimal responses to conventional pharmacological treatments. Evidence suggests that aerobic exercise (AE) and mindful breathing (MB) can serve as powerful non-pharmacological modulators of the central and autonomic nervous systems. This protocol outlines a randomized clinical trial (RCT) to evaluate the individual and synergistic effects of these interventions in a Saudi Arabian clinical population.
Major Depressive Disorder (MDD) is no longer viewed merely as a psychological condition but as a systemic, multi-faceted public health crisis. According to the World Health Organization and the latest Global Burden of Disease (GBD) analysis, MDD is a primary driver of global disability, defined by persistent feelings of sadness, anhedonia, sleep disturbances, and diminished capacity for daily functioning . Globally, it affects more than 280 million people.
In Saudi Arabia, the rising prevalence of MDD necessitates a shift toward "Integrative Psychiatry," where lifestyle medicine serves as a core pillar. Despite the availability of pharmacological and psychotherapeutic treatments, many individuals experience suboptimal outcomes, relapse, or treatment resistance, with the STAR*D study highlighting that only about one-third of patients achieve full remission after their first course of antidepressant medication . Furthermore, the side effects of conventional medications, such as weight gain and metabolic syndrome, often lead to premature discontinuation.
While the individual antidepressant effects of exercise and mindful breathing are well-documented, significant gaps remain. Existing literature indicates that AE "primes" the brain by increasing neuroplasticity and reward processing. Mindful breathing, conversely, stabilizes the autonomic nervous system and reduces anxiety. Combining these two low-cost, non-pharmacological interventions may provide a superior "biopsychosocial" approach to MDD recovery that neither could achieve alone. Modern psychiatry recognizes that a patient can be "less depressed" while still having a poor Quality of Life (QoL). Exercise is uniquely positioned to improve QoL because its benefits are "transdiagnostic", improving physical vitality, sleep quality, and social engagement simultaneously.
and a baseline Hamilton Depression Rating Scale (HAM-D) score ≥ 17.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Group 1: Aerobic Exercise (AE) Administration The AE protocol is designed to achieve the moderate-intensity threshold * Warm-up: 5-10 minutes of low-intensity walking. * Core Phase: 30 minutes of continuous aerobic activity (walking). * Cool-down: 5 minutes of slow walking and static stretching. Group II: Mindful Breathing (MB) Administration * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for 4 seconds and exhaling slowly for 6 seconds (approximately 6 breaths per minute). * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. Group III: Control Group (Standard Care) : Participants will continue their prescribed pharmacological treatment and any existing psychotherapy or physiotherapy sessions.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (AE) | Experimental | Other: Aerobic exerciseThe AE protocol is designed to achieve the moderate-intensity threshold (SMD = -0.91), which has been identified as the most effective for symptom reduction (16). * Warm-up: 5-10 minutes of low-intensity walking and dynamic stretching. * Core Phase: 30 minutes of continuous aerobic activity (walking or Stationary Cycling). * Intensity Monitoring: Heart rate (HR) will be monitored using wearable sensors. Target intensity is set at 60-75% of the Heart Rate Reserve (HRR) or a Rating of Perceived Exertion (RPE) of 12-14 on the Borg Scale. * Cool-down: 5 minutes of slow walking and static stretching. |
| Mindful Breathing (MB) | Experimental | Other: Mindful BreathingThe MB protocol focuses on "Top-Down" emotional regulation and "Bottom-Up" autonomic stabilisation. * Technique: Participants will be taught Diaphragmatic Resonant Breathing. This involves inhaling through the nose for four (4) seconds and exhaling slowly for six (6) seconds (approximately 6 deep breaths per minute). * Mindfulness Component: During the breathing, participants are instructed to maintain "non-judgmental awareness," acknowledging stray thoughts and gently returning focus to the sensation of air entering and leaving the body. * Duration: 15 minutes per session, conducted in a seated, comfortable position with eyes closed or a soft gaze. |
| Control Group (Standard Care) Standard Treatment | Other | Other: Aerobic exercise, Other: Mindful BreathingParticipants will continue their prescribed pharmacological treatment and any existing psychotherapy and physiotherapy sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.
- A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile
Key exclusion criteria (4 listed)
- Patients with high suicidal ideation
- Patients with a history of psychosis or bipolar disorder
- Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).
- Concurrent participation in other structured exercise/mindfulness trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAlso: walking, cardiovascular exerciseAerobic or cardiovascular exercise is characterized by activities that engage large muscle groups, including walking, jogging, or cycling. Regular aerobic exercise can improve cardiovascular health, endurance, and overall fitness. | Other | Aerobic Exercise (AE), Control Group (Standard Care) Standard Treatment |
| Mindful BreathingAlso: diaphragmatic breathing, deep breathingMindful breathing can include diaphragmatic breathing, deep breathing, and controlled breathing techniques, which focus on regulating and optimizing the process of inhalation and exhalation. These techniques enhance respiratory function, increase lung capacity, and promote relaxation by activating the parasympathetic nervous system. Therefore, they have been used in various therapeutic contexts to manage stress, anxiety, and mood disorders, including MDD, by regulating emotions and the stress response. | Other | Control Group (Standard Care) Standard Treatment, Mindful Breathing (MB) |
Primary outcome
Depressive symptom severity
Time frame: Baseline, Week 4,8, and a 16-week
Depressive symptom severity will be assessed using the Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. For MDD, a baseline Hamilton Depression Rating Scale (HAM-D) score of ≥ 17 is required. Reduction in Hamilton Depression Rating Scale (HAM-D) scores is the primary outcome measure.
3 secondary outcomes
Quality of life (QoL) 1: Quality of Life (WHOQOL-BREF)
Time frame: WHOQOL-BREF: baseline and week 16.
Quality of life (QoL)2 : Anxiety Symptoms
Time frame: Baseline, Week 4,8, and a 16-week
Quality of life (QoL) 3: Sleep Quality
Time frame: Baseline, Week 4, Week 8, and Week 16.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background1. WHO. Depressive disorder (depression): World Health Organization; 2025 [Available from: https://www.who.int/news-room/fact-sheets/detail/depression.
- Background: PubMed 41092927GBD 2023 Demographics Collaborators. Global age-sex-specific all-cause mortality and life expectancy estimates for 204 countries and territories and 660 subnational locations, 1950-2023: a demographic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 18;406(10513):1731-1810. doi: 10.1016/S0140-6736(25)01330-3. Epub 2025 Oct 12.
- Background: PubMed 39523315Alnaim MA, Alghamdi AH, Aljawair MR, Alhadi FA, Alomair AM, Alsaad A. Depression among Saudi international university students and its associated risk factors. BMC Public Health. 2024 Nov 11;24(1):3101. doi: 10.1186/s12889-024-20565-y.
- Background: PubMed 37491091Pigott HE, Kim T, Xu C, Kirsch I, Amsterdam J. What are the treatment remission, response and extent of improvement rates after up to four trials of antidepressant therapies in real-world depressed patients? A reanalysis of the STAR*D study's patient-level data with fidelity to the original research protocol. BMJ Open. 2023 Jul 25;13(7):e063095. doi: 10.1136/bmjopen-2022-063095.
- Background: PubMed 39935805Romero Garavito A, Diaz Martinez V, Juarez Cortes E, Negrete Diaz JV, Montilla Rodriguez LM. Impact of physical exercise on the regulation of brain-derived neurotrophic factor in people with neurodegenerative diseases. Front Neurol. 2025 Jan 28;15:1505879. doi: 10.3389/fneur.2024.1505879. eCollection 2024.
- Background: PubMed 36611488Komariah M, Ibrahim K, Pahria T, Rahayuwati L, Somantri I. Effect of Mindfulness Breathing Meditation on Depression, Anxiety, and Stress: A Randomized Controlled Trial among University Students. Healthcare (Basel). 2022 Dec 22;11(1):26. doi: 10.3390/healthcare11010026.
- Background: PubMed 42270109Bin Muaythir S, Bello B, Mshunqane N, Ramano E, Magida N. Effect of Aerobic exercise on depression symptoms and quality of life in Patients with major depressive disorder: a systematic review Protocol. BMJ Open. 2026 Jun 10;16(6):e112841. doi: 10.1136/bmjopen-2025-112841.
- Background: PubMed 33044541Marquez DX, Aguinaga S, Vasquez PM, Conroy DE, Erickson KI, Hillman C, Stillman CM, Ballard RM, Sheppard BB, Petruzzello SJ, King AC, Powell KE. A systematic review of physical activity and quality of life and well-being. Transl Behav Med. 2020 Oct 12;10(5):1098-1109. doi: 10.1093/tbm/ibz198.
- Background: PubMed 28286859Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14.
- Background: PubMed 32084211Jenkins DG, Quintana-Ascencio PF. A solution to minimum sample size for regressions. PLoS One. 2020 Feb 21;15(2):e0229345. doi: 10.1371/journal.pone.0229345. eCollection 2020.
- Individual participant dataSharing planned: No. Indirect identifiers will be used through coded participant IDs. Direct identifiers will be stored separately from research data. Use participant codes on all study forms; store consent forms separately; keep electronic data on password-protected/encrypted devices or servers; keep paper CRFs in locked cabinets; restrict access to PI and authorized research staff only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saad Bin Muaythir, Master principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Mindful Breathing in people with Major Depressive Disorder (MDD), run by University of Pretoria at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad A Bin Muaythir, Master (+966568200040, u24122336@tuks.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity (time frame: Baseline, Week 4,8, and a 16-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07625163, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.